NCT01865864

Brief Summary

to test whether using CPAP can restore the normal pattern of drop of blood pressure during sleep.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2008

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

December 26, 2008

Last Update Submit

May 28, 2013

Conditions

Keywords

CPAPdiurnal blood pressureobstructive sleep apnea24 hour blood pressure monitor

Outcome Measures

Primary Outcomes (1)

  • drop of Blood pressure at night

    6 weeks

Study Arms (2)

1

Compliant with CPAP

2

noncompliant with CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obstructive sleep apnea patients age over 18 years

You may not qualify if:

  • Patients who have a normal diurnal sleep pattern (i.e. decrease of more than 30% of the systolic BP at night time)
  • Patients who are on three or more antihypertensives whose blood pressure is not controlled.
  • Patients previously treated with CPAP therapy within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Tower

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Suzzane El-Sayegh, MD

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 26, 2008

First Posted

May 31, 2013

Study Start

July 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations